DEVICE: Electrode for ABL analyzers (05700699456038)

Download: XML | JSON

Device Identifier (DI) Information

Electrode for ABL analyzers
945-603
945-603
Radiometer Medical ApS
05700699456038
GS1
1
E1001 Reference electrode for ABL7XX/8XX
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Reference electrode IVD An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CHL ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
MQM BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
KHP ACID, LACTIC, ENZYMATIC METHOD
GHS ASSAY, CARBOXYHEMOGLOBIN
JGS ELECTRODE, ION SPECIFIC, SODIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
CGA GLUCOSE OXIDASE, GLUCOSE
CIG DIAZO COLORIMETRY, BILIRUBIN
CGL ELECTRODE, ION BASED, ENZYMATIC, CREATININE
KQI ASSAY, FETAL HEMOGLOBIN
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 01, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
CLOSE